This invention relates to a device, or instrument, for obtaining a strip biopsy from the endocervical canal of the human uterine cervix.
Accurate endocervical histology is essential in the management of patients with abnormal Papanicolaou (Pap) smears to determine whether or not the endocervical canal is involved by the disease process. At the present time, upon evidence of an abnormal Pap smear, the patient is subjected to a surgical operative procedure in the hospital, under anesthesia, in which cone-shaped portions of tissue are taken from the endocervical canal for biopsy purposes. The instrument normally employed is a conventional scalpel. The routine procedure may cause extensive blood loss, is traumatic, time-consuming and expensive. The long term effects may also possibly give rise to possible infertility and/or cervical incompetence or stenosis during pregnancy due to the amount of tissue taken in such a biopsy procedure and the resulting scar tissue formation.
It has also been proposed, in order to avoid the hospitalization procedure above noted, to utilize an endocervical curette, normally used in a dilatement and curettage procedure, for the purpose of obtaining tissue material for a biopsy. The endocervical tissue scrapings normally obtained with such curettes are fragmented, non-coherent tissue, and do not include stroma (that tissue under the epithelial lining of the cervix uteri). Furthermore, the present endocervical curette designs do not enable a pathologist to receive a tissue specimen free of excessive blood or other contaminating debris. Fragmented, non-coherent, contaminated tissue is difficult to interpret histopathologically. Additionally, specimens of stroma tissue are needed for diagnosis of invasive cancer cells.
In addition to the above-described drawbacks of the present endocervical curettes, it is very difficult to maintain a very high degree of sharpness on their cutting edges under frequent use conditions.
The major objects of the present invention are to obviate the above-described drawbacks of the present curette design, so that relatively noncontaminated, coherent, elongated strips of relatively thick endocervical tissue (including stroma tissue) may be obtained for biopsy. These and other objects will become apparent from the following description of the invention.